Percutaneous transluminal coronary angioplasty (PTCA) is a procedure that is well established for the treatment of blockages, lesions, stenosis, thrombus, etc. present in body lumens such as the coronary arteries and/or other vessels.
A widely used form of percutaneous coronary angioplasty makes use of a dilatation balloon catheter, which is introduced into and advanced, through a lumen or body vessel until the distal end thereof is at a desired location in the vasculature. Once in position across an afflicted site, the expandable portion of the catheter, or balloon, is inflated to a predetermined size with a fluid at relatively high pressures. By doing so the vessel is dilated, thereby radially compressing the atherosclerotic plaque of any lesion present against the inside of the artery wall, and/or otherwise treating the afflicted area of the vessel. The balloon is then deflated to a small profile so that the dilatation catheter may be withdrawn from the patient's vasculature and blood flow resumed through the dilated artery.
In angioplasty procedures of the kind described above, there may be restenosis of the artery, which either necessitates another angioplasty procedure, a surgical by-pass operation, or some method of repairing or strengthening the area. To reduce restenosis and strengthen the area, a physician can implant an intravascular prosthesis for maintaining vascular patency, such as a stent, inside the artery at the lesion.
Stents, grafts, stent-grafts, vena cava filters, expandable frameworks, and similar implantable medical devices, collectively referred to herein as stents, are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneously. Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, fallopian tubes, coronary vessels, secondary vessels, etc. They may be self-expanding, expanded by an internal radial force, such as when mounted on a balloon, or a combination of self-expanding and balloon expandable (hybrid expandable).
Prior to delivery, a stent or stents may be retained on a portion of the delivery catheter by crimping the stent onto the catheter, retaining the stent in a reduced state about the catheter with a removable sheath, sleeve, sock or other member or members, or by any of a variety of retaining mechanisms or methods. Some examples of stent retaining mechanisms are described in U.S. Pat. No. 5,681,345; U.S. Pat. No. 5,788,707; U.S. Pat. No. 5,968,069; U.S. Pat. No. 6,066,155; U.S. Pat. No. 6,096,045; U.S. Pat. No. 6,221,097; U.S. Pat. No. 6,331,186; U.S. Pat. No. 6,342,066; U.S. Pat. No. 6,350,277; U.S. Pat. No. 6,443,880; and U.S. Pat. No. 6,478,814.
Bodily vessels that branch off into further vessels are termed bifurcated vessels. Some bifurcated vessels have stenotic lesions and disease requiring treatment of the parent vessel, while preserving access to the side branch vessel. A dual lumen catheter system used to stent a bifurcation site allows the physician to maintain guide wires in both the parent and side branch vessels. These guide wires can then allow post dilation balloons to be guided into the bifurcation through a deployed stent. In a dual lumen device, the stent cell that the side branch lumen penetrates aligns itself into the side branch vessel. Proper alignment assures that the carina gets good stent coverage and that the stent does not obstruct the side branch vessel.
A stent delivery system employing a stent assembly with branches intended for deployment in adjacent branches of a vessel bifurcation allows placement of a portion of the assembly in both a primary passage, such as an artery, and a secondary passage, such as a side branch artery. Additionally, these stents generally have an opening that allows for unimpeded blood flow into the side branch artery. However, due to use of two separate lumens, the resulting profile is increased and the cross-section takes on an oval shape, reducing stent contact and ease of stent rotation.
Thus, a need exists to provide a catheter that is capable of allowing a medical device, such as a stent, to be easily maneuvered and aligned at a vessel bifurcation or other location. Various devices and methods described herein address these issues by providing a catheter system with inventive balloon folding designs.
All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.
Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims.